"supplementing" the DSHEA: Congress must invest the FDA with greater regulatory authority over nutraceutical manufacturers by amending the dietary supplement health and education act

California Law Review

Volumn 98, Issue 2, 2010, Pages 439-480

  Azizi, Rahi ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

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EID: 77956135434     PISSN: 00081221     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (375)

1. Caleb Hellerman, No Scientific Evidence Dietary Supplements Slow Aging, CNN, May 9, 2007, http://wwwxim.com/2007/HEALTH/04/09/chasing.supplements/index. html.
2. Id. Caleb Hellerman, No Scientific Evidence Dietary Supplements Slow Aging, CNN, May 9, 2007, http://wwwxim.com/2007/HEALTH/04/09/chasing. supplements/index.html.
3. Id. Caleb Hellerman, No Scientific Evidence Dietary Supplements Slow Aging, CNN, May 9, 2007, http://wwwxim.com/2007/HEALTH/04/09/chasing. supplements/index.html.
4. Id. Caleb Hellerman, No Scientific Evidence Dietary Supplements Slow Aging, CNN, May 9, 2007, http://wwwxim.com/2007/HEALTH/04/09/chasing. supplements/index.html.
5. - 21 U.S.C. § 321(c) (1994).
6. - 21 U.S.C. § 321(g)(1)(b) (1994) (defining drugs as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease").
7. Inside Clinical Trials: Testing Medical Products in People, FDA CONSUMER MAG. (SPECIAL REPORT), Jan. 2006, available at http://permanent.access.gpo.gov/ lpsl609/www.fda.gov/fdac/special/testtubetopatient/trials.html (last visited Apr. 25, 2010).
8. Id. Inside Clinical Trials: Testing Medical Products in People, FDA CONSUMER MAG. (SPECIAL REPORT), Jan. 2006, available at http://permanent.access. gpo.gov/lpsl609/www.fda.gov/fdac/special/testtubetopatient/trials.html (last visited Apr. 25, 2010).
9. Margaret Gilhooley, Herbal Remedies and Dietary Supplements: The Boundaries of Drug Claims and Freedom of Choice, 49 FLA. L. REV. 663, 679-81 (1997).
10. See Peter A. Vignuolo, The Herbal Street Drug Crisis: An Examination of the Dietary Supplement Health and Education Act of 1994, 21 SETON HALL LEGIS. J. 200, 202-05 (1997) (discussing the importance manufacturers placed on labeling in marketing the weight loss supplement ephedra).
11. Peter J. Cohen, Science, Politics, and the Regulation of Dietary Supplements: It's Time to Repeal DSHEA, 31 AM. J.L. & MED. 175, 186-87 (2005).
12. Kristen N. Nichols, Nutraceuticals: In the Realm of Consumer Protection, Is the United States' Regulation Too Much or Not Enough, 9 MICH. ST. U.J. MED. & L. 369, 369-70 (2005);
13. see also 21 U.S.C § 321(a) (1994).
14. Nichols, supra note 12, at 369-70.
15. Dietary Supplement Health and Education Act of 1994 (DSHEA), Pub. L. No. 103-417, 108 Stat. 4325 (1994) (codified as amended in scattered sections of 21 U.S.C). The DSHEA became law on October 25, 1994.
16. See id. (stating multiple justifications for enactment of the DSHEA, including that "the nutritional supplement industry is an integral part of the economy of the United States, " that the industry "consistently projects a positive trade balance, " that "dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare, " and that consumers "should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements");
17. see also Ali Sachani, Warning: Over-Consumption of This Product May Be Harmful to Your Health! Applying the Proposed Canadian Natural Health Product Regulatory Framework to Clarify the Level of Substantiation Required for Dietary Supplements, 9 Sw. J.L. & TRADE AM. 391, 394 (2003) (suggesting that the current regime "appears to value big business over consumer health by presuming that dietary supplements and their claims of nutritional support are safe").
18. - 21 U.S.C § 342(f)(1) (2006).
19. See Lauren J. Sloane, Herbal Garden of Good and Evil: The Ongoing Struggle of Dietary Supplement Regulation, 51 ADMIN. L. REV. 323, 332 (1999) (discussing the rise of products introduced to the market that have been proven neither safe nor effective).
20. Roseanne B. Termini, Pharmanex, Inc. v. Shalala: A Wake Up Call for Congress and a Not So Bitter Pill for the FDA, 26 OHIO N.U.L. REV. 269, 280 (2000) (identifying numerous adverse side effects, including dizziness, nausea, heart palpitation, and death, linked to dietary supplements).
21. See Jennifer Sardina, Misconceptions and Misleading Information Prevail-Less Regulation Does Not Mean Less Danger to Consumers: Dangerous Herbal Weight Loss Products, 14 J.L. & HEALTH, 107, 131-32 (suggesting that enactment of consumer-oriented legislation would increase the credibility and prosperity of the dietary supplement industry, because more consumers will gain confidence in the system).
22. Laura A.W. Khatcheressian, Regulation of Dietary Supplements: Five Years of DHSEA, 54 FOOD & DRUG L.J. 623, 624 (1999) (describing the FDA's changing "level and focus" of concern with dietary supplements since the FDCA's passage in 1938).
23. Federal Food Drug and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended in scattered sections of 21 U.S.C.).
24. Khatcheressian, supra note 20, at 624.
25. Id. (describing the obstacles the FDA faced in regulating dietary supplements).
26. Id. at 625.
27. See, e.g., United States v. Two Plastic Drums, 984 F.2d 814 (7th Cir. 1993) (holding that because "encapsulated black currant oil, " the single active ingredient of a dietary supplement, is not a "food additive, " the FDA cannot require the manufacturer to prove that the substance is safe);
28. see also United States v. Twenty-Nine Cartons of an Article of Food, 987 F.2d 33 (1st Cir. 1993) (holding, like the Seventh Circuit, that black currant oil is properly classified as "food" and therefore subject to minimal regulation).
29. Regulation of Dietary Supplements, 58 Fed. Reg. 33, 690-01 (June 18, 1993) (to be codified at 21 C.F.R. ch. I);
30. see also Carter Anne McGowan, Learning the Hard Way: L- Tryptophan, the FDA, and the Regulation of Amino Acids, 3 CORNELL J.L. & PUB. POL'Y 383, 399-400 (1994) (defining eosinophilia-myalgia as a systemic illness characterized by fever, muscle aches, cough, shortness of breath, skin swelling, and skin rash).
31. Khatcheressian, supra note 20, at 624-25.
32. Id.
33. Id. at 625-26.
34. See Cohen, supra note 11, at 219 (identifying Senator Hatch as one of the DSHEA's main sponsors);
35. see also 139 CONG. REC. S4577 (daily ed. Apr. 7, 1993) (statement of Sen. Hatch) (articulating reasons for supporting the amendment).
36. Sloane, supra note 17, at 325 (characterizing the DSHEA as the product of "overwhelming public pressure").
37. Jennifer J. Spokes, Confusion in Dietary Supplement Regulation: The Sports Products Irony, 77 B.U. L. REV. 181, 190 (1997).
38. Id. Jennifer J. Spokes, Confusion in Dietary Supplement Regulation: The Sports Products Irony, 77 B.U. L. REV. 181, 190 (1997).
39. Id. at 191. The regulations concerning dietary supplements are comparable to those governing the sale of food.
40. See 21 U.S.C. § 342(f)(1) (2005);
41. see also Robert G. Pinco & Todd H. Halpern, Guidelines for the Promotion of Dietary Supplements: Examining Government Regulation Five Years After Enactment of the Dietary Supplement Health and Education Act, 54 FOOD & DRUG L.J. 567, 567-68 (1999) (clarifying the distinction between food additives and dietary supplements).
42. Khatcheressian, supra note 20, at 624.
43. Sloane, supra note 17, at 332.
44. Federal Food Drug and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended in scattered sections of 21 U.S.C).
45. See Michael A. McCann, Dietary Supplement Labeling: Cognitive Biases, Market Manipulation, & Consumer Choice, 31 AM. J.L. & MED. 215, 219 (2005) (describing consumers' positive views of dietary supplements).
46. See William J. Skinner, Allowable Advertisements for Dietary Supplements, 5 J. PHARM. & L. 309, 309-10 (1996) (speculating that the DSHEA was "solely responsible for the purchase of many telephone answering machines by Congressional committee staff offices and Members of Congress").
47. - 21 U.S.C. § 321(g)(1) (2006).
48. Federal Food Drug and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended in scattered sections of 21 U.S.C).
49. - 21 U.S.C § 355(a)(1) (2006) ("No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of this section is effective with respect to such drug."). The DSHEA contains no comparable provision.
50. McCann, supra note 38, at 220;
51. see also 21 U.S.C § 350(b) (1994 & Supp. Ill 1998);
52. Pearson v. Shalala, 164 F.3d 650, 652 (D.C. Or. 1999) (holding that "[t]he actual sale of dietary supplements is regulated only when the supplement contains a 'new dietary ingredient
53. - 21 U.S.C.A. § 350b (Supp. 1998), or poses a safety risk, id. § 342(f)").
54. - 21 U.S.C. § 350b(c)
55. defines a new dietary ingredient as one "that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994." Under § 350(b) of that statute, while the manufacturer is not obligated to conduct tests, it must present data to the FDA seventy-five days prior to releasing the product indicating that ingredient is reasonably "expected to be safe." An exception applies to unaltered ingredients not marketed as dietary supplements, but present within the food supply as an article of food prior to October 15, 1994.
56. - 21 U.S.C. § 342(0(1) (2000 & Supp. V 2005).
57. Id. 21 U.S.C. (2005)
58. See Sean Harmon, Melatonin Mania: Can the FDA Regulate Hormonal Dietary Supplements to Protect Consumer Interests in Light of the Dietary Supplement Health and Education Act of 1994?, 22 U. DAYTON L. REV. 77, 91 (1996) (stating that one purpose of the DHSEA is to "stop certain FDA actions which directly prevented the free market sale of dietary supplements").
59. Id. at 91 (stating that the DSHEA limits the FDA's ability to act proactively).
60. McCann, supra note 38, at 220-21.
61. Id. at 222 (suggesting that "dietary supplements are often marketed as medicinal products rather than as food products").
62. Tennini, supra note 18, at 278.
63. - 21 U.S.C. § 342(f)(1)(A) (2000).
64. Dietary Supplement Health and Education Act, Pub. L. No. 103-417, 108 Stat. 4325 (1994) (codified as amended at scattered sections of 21 U.S.C).
65. FDA, Dietary Supplements: Overview, http://www.fda.gov/Food/ DietarySupplements/Consumerlnformation/ucml10417.htm#what (last visited Apr. 25, 2010).
66. McCann, supra note 38, at 244.
67. Id.
68. Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325 (1994) (codified as amended at scattered sections of 21 U.S.C). Part III of this paper will discuss the types of labeling claims the FDA regulates and prohibits.
69. On June 22, 2007, the FDA announced a final rule-effective as of August 24, 2007- requiring dietary supplement manufacturers to ensure that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled. The regulations provide instructions to manufacturers on how to implement quality control measures and prevent contamination.
70. See 21 C.F.R. § 111.3 (2008);
71. see also Press Release, Food & Drug Admin., FDA Issues Dietary Supplements Final Rule (June 22, 2007), available at http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/2007/ucml08938.htm. Neither the rule nor the announcement requires manufacturers to conduct controlled, double-blind studies involving patients to determine safety and efficacy-the testing protocol that this Comment advocates.
72. See McCann, supra note 38, at 218-20 (stating that the billion-dollar supplement industry evidences Americans' concern with maintaining and improving their overall health).
73. Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325, 4326 (1994).
74. See McCann, supra note 38, at 224 ("Consumers who select supplements because they regard conventional treatments as expensive are almost twice as likely to earn incomes below the poverty line, significantly more likely to report poorer health status, and four times more likely to be uninsured.");
75. Ha T. Tu & J. Lee Hargraves, CTR. FOR STUDYING HEALTH SYS. CHANGE, DATA BULLETIN NO. 28: HIGH COST OF MEDICAL CARE PROMPTS CONSUMERS TO SEEK ALTERNATIVES (2004), available at http://www.hschange.com/CONTENT/722/.
76. - 21 U.S.C. §321.
77. McCann, supra note 38, at 224.
78. Sloane, supra note 17, at 332-33 (1999) (arguing that "millions of Americans are potentially more susceptible to unknown hazards by their consumption of products that are regulated far less stringently than prescription medicines").
79. McCann, supra note 38, at 224.
80. Id.
81. Id.
82. But see Bruce N. Ames, The Causes and Prevention of Cancer: The Role of Environment, CA51 ALI-ABA 49 (1995) (suggesting that some antioxidants, like vitamin C and E, can reduce environmental damage to cells that can trigger the onset of cancer).
83. Id. at 225 (stating that adolescents have "a greater tendency than adults to take dangerous risks, weigh short-term consequences more heavily than long-term consequences, and act impulsively").
84. Id. at 226.
85. Id.
86. Id.
87. Id.
88. see also Khatcheressian, supra note 20, at 629 (describing the initial classification and marketing of "androstenedione, " an anabolic steroid, as a dietary supplement, and noting that Mark McGwire was one famous user of this product).
89. Ashish R. Talati, Dietary Supplement Adverse Event Reports: Review and Analysis, 64 FOOD & DRUG L.J. 503, 506 (2009).
90. Id. Ashish R. Talati, Dietary Supplement Adverse Event Reports: Review and Analysis, 64 FOOD & DRUG L.J. 503, 506 (2009).
91. Id. Ashish R. Talati, Dietary Supplement Adverse Event Reports: Review and Analysis, 64 FOOD & DRUG L.J. 503, 506 (2009).
92. Id. at 510.
93. FDA, Recall Notice, Event ID 26400 (June 2, 2003);
94. FDA, Recall Notice, Event ID 44925 (July 2, 2008);
95. FDA, Recall Notice, Event ID 52648 (July 27, 2009).
96. FDA, Recall Notice, Event ID 26400;
97. see also Stephen TV Kaminski, Must Employers Pay for Viagra? An Americans with Disabilities Act Analysis Awf-Bragdon and Sutton, 4 DEPAUL J. HEALTH CARE L. 73, 76 (2000) (describing the initial development of Viagra for the treatment of angina, and the discovery of its incidental effects on erectile dysfunction).
98. Kaminski, supra note 77, at 77.
99. FDA, Recall Notice, Event ID 26400.
100. FDA, Recall Notice, Event ID 52547 (July 20, 2009);
101. FDA, Recall Notice, Event ID 52648 (July 27, 2009);
102. FDA, Recall Notice, Event ID 52731 (Aug. 6, 2009).
103. FDA, Recall Notice, Event ID 49120 (Aug. 1, 2008).
104. Saundra Young, Stop Using Hydroxycut Products, FDA Says, CNN, May 1, 2009, http://ww.crm.cora2009/HEALTH/05/01/hdroxycut.fda.recall/index.html.
105. Talati, supra note 72, at 512.
106. Id.
107. Id.
108. Press Release, Food & Drug Admin., Iovate Health Sciences U.S.A., Inc. Voluntarily Recalls Hydroxycut-Branded Products (May 1, 2009), http://www.fda.gov/Safety/Recalls/ucml45164.htm.
109. Judd Cooper Legum, The Dangers of DSHEA: A Case for Expanded FDA Authority Over Dietary Supplements, 6 MICH. ST. J. MED. & L. 103, 105 (2002).
110. Cohen, supra note 11, at 181 (arguing that the FDA's regulation of dietary supplements prior to the DSHEA was based on "the belief that only strong government action could protect individuals from harm that they had no way of combating on their own, " rather than the importance of access to dietary supplements).
111. John E. Villafranco & Andrew B. Lustigman, Regulation of Dietary Supplement Advertising: Current Claims of Interest to the Federal Trade Commission, Food and Drug Administration and National Advertising Division, 62 FOOD & DRUG L.J. 709, 714 (2007).
112. See id. at 709-10 (stating that "under a liaison agreement, the Federal Trade Commission (FTC) acts as the primary regulator of dietary supplement advertising and the Food
113. and Drug Administration (FDA) possesses primary enforcement responsibility for dietary supplement claims made in 'labeling'");
114. see also 21 U.S.C. 343-2 (2006) (distinguishing labels from advertisements when the latter is "physically separate from the dietary supplements").
115. - 15 U.S.C. § 52(a)(1) (2006) (vesting the FTC with authority to prohibit false advertisement that "is likely to induce, directly or indirectly, the purchase in or having an effect upon commerce, of food, drugs, devices, services, or cosmetics"). The FDA can and does aid the FTC in its investigation of nutraceutical advertising, supplying it with the scientific information it needs.
116. See Doughlas W. Hyman, The Regulation of Health Claims in Food Advertising: Have the FTC and the FDA Finally Reached a Common Ground?, 51 FOOD & amp; DRUG L.J. 191, 192(1996).
117. - 21 U.S.C. § 343(b), (f) & (i) (1994).
118. Id. ("A dietary ingredient shall not be required to be listed if it is not present in a significant amount." Section 343(b) does not define "significant amount.").
119. Food Labeling Regulation, Amendments;
120. Food Regulation Uniform Compliance Date; and New Dietary Ingredient Premarket Notification;
121. Final Rules, 62 Fed. Reg. 49, 826 (Sept. 23, 1997) (to be codified at 21 C.F.R. pt.101).
122. - 21 U.S.C. § 321(ff)(2)(C) (1994).
123. Margaret Gilhooley, supra note 9, 687.
124. - 21 U.S.C. §343(r)(6) (1994).
125. See id.; 21 U.S.C. (1994).
126. see also Trisha L. Beckstead, Caveat Emptor, Buyer Beware: Deregulation of Dietary Supplements upon Enactment of the Dietary Supplement Health and Education Act of 1994, 11 SAN JOAQUIN AGRIC. L. REV. 107, 113-15 (2001) (defining a "health claim" as one that associates a supplement with disease prevention).
127. - 21 U.S.C. § 343 (r)(6)(A) (1994) (defining a permissible structure/function claim as one that "describes the role of a nutrient or a dietary ingredient intended to affect the structure or function in humans").
128. See Cohen, supra note 11, at 187 ("[W]hen supplement manufacturers do imply efficacy in treating disease, the government's ability to enforce DSHEA's minimal standards is subject to significant limitations.").
129. Margaret Gilhooley, supra note 9, at 685 (describing the increased number of structure/function claims being made for dietary supplements since passage of the DSHEA).
130. - 21 C.F.R. § 101.14(a)(1) (1998) (describing a health claim as "a claim that characterizes the relationship of any substance to a disease or health-related condition").
131. Id. 21 C.F.R. (1998)
132. - 21 C.F.R. § 101.14(d).
133. Id. 21 C.F.R.
134. - 21 C.F.R. § 101.70 (2005) (investing the FDA with discretionary authority to approve or reject health claims);
135. - 5 U.S.C. § 553 (2006) (investing executive agencies with broad rulemaking authority).
136. See generally James Robert Dean, Jr., FDA at War: Securing the Food that Secured Victory, 53 FOOD & DRUG L.J. 453, 509-11 (1998) (discussing the FDA's reliance on the APA in issuing rules).
137. - 21 C.F.R. § 101.14(c)
138. (stating that the FDA will authorize a health claim "when it determines, based on the totality of publicly available scientific evidence, " including "evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles, " that "there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence")
139. See Cohen, supra note 11, at 187 (stating that dietary supplements containing health claims that are not preapproved are "deemed misbranded and unapproved new drugs within the meaning of U.S.C. § 321(g)(1)(B) and may be seized or enjoined from being sold" under 21 U.S.C. §§ 333, 334);
140. see also 21 C.F.R. § 101.14(c) (suggesting that the basis for substantiation is the "signficant scientific agreement" standard).
141. - 21 C.F.R.§ 101.14(e).
142. - 21 U.S.C. § 343(r)(6)(B).
143. See Pearson v. Shalala, 164 F.3d 650, 657 (D.C. Cir. 1999) (holding that a restriction on potentially misleading health claims that are curable through disclaimers violates the First Amendment). Part IV of this Comment will discuss the role of the First Amendment within the context of health and structure/function claims.
144. Id. 164 F.3d 650, (1999)
145. Id. 164 F.3d 650, (1999)
146. - 21 U.S.C. § 343(r)(6)(A) (1994).
147. Sachani, supra note 15, at 400.
148. Apart from its general or purported meaning, a patient with glaucoma or macular degeneration might infer from the label that the product can slow or reverse the progression of her disease, perhaps even restore lost vision.
149. - 21 U.S.C. § 343(r)(6)(B). The DSHEA requires that a manufacturer "ha[ve] substantiation" regarding the truthfulness of a claim; it does not require the manufacturer to submit evidence of substantiation to the FDA.
150. See Stephen H. McNamara, So You Want to Market a Food and to Make a Health Claim-How Far Can You Go? What Rules of Law Will Govern the Claims You Want to Make, 53 FOOD & DRUG L.J. 421, 431 (1998) (suggesting that there is little to no preclearance scrutiny that the FDA applies to structure/function claims).
151. - 21 U.S.C. § 343(r)(6)(c).
152. Id. 21 U.S.C.
153. See MARK A. KASSEL, FROM A HISTORY OF NEAR MISSES: THE FUTURE OF DIETARY SUPPLEMENT REGULATION, 49 FOOD & DRUG L.J. 237, 238 (1994) (arguing that "Americans have come to rely so heavily on government regulation of commerce that it is often assumed that dietary supplement claims by manufacturers and advertisers would not reach consumers if they were not true");
154. see also Sardina, supra note 19, at 121 (stating that some consumers took the dietary supplement L-tryptophan because they believed that the FDA had monitored this product).
155. Cohen, supra note 11, at 186.
156. But see Robert Pinco & Paul D. Rubin, Ambiguities of the Dietary Supplement and Health Education Act of 1994, 51 FOOD & DRUG L.J. 383, 390 (1996) (suggesting that the FDA might prohibit a statement of this kind as an impermissible disease claim).
157. See Termini, supra note 18, at 276 (stating that prior to Congress's adoption of the DSHEA, the "FDA used its power of seizure, prosecution or the threat of treating health claims of dietary supplements under the tough 'new drug' approval standards to control the dietary supplement industry").
158. Pearson v. Shalala, 164 F.3d 650, 659-60 (D.C. Or. 1999).
159. See Barbara A. Noah, A Review of the New York State Task Force on Life & the Law's Report: Dietary Supplements: Balancing Consumer Choice & Safety, 33 J.L. MED. & ETHICS 860, 862 (2005) (suggesting that consumers "may fail to appreciate the distinction between a true therapeutic claim and a structure or function claim, " and may "misinterpret or ignore the disclaimer").
160. See McCann, supra note 38, at 232;
161. see also 15 U.S.C. § 52 (2006) (prohibiting the dissemination of false advertisements).
162. McCann, supra note 38, at 250.
163. Iona N. Kaiser, Dietary Supplements: Can the Law Control the Hype, 37 Hous. L. REV. 1249, 1271 (2000).
164. Id. Iona N. Kaiser, Dietary Supplements: Can the Law Control the Hype, 37 Hous. L. REV. 1249, (2000)
165. Id. at 1271-72.
166. Id. at 1272.
167. - 21 U.S.C § 342(f)(1) (1994).
168. - 21U.S.C.§ 342(f)( 1 )(D) (1994).
169. See 69 Fed. Reg. 6788, 6822-23 (Feb. 11, 2004) (to be codified at 21 C.F.R. pt. 119). The determination that something poses an unreasonable risk involves a balancing test that is "well-established in tort law, " in which "the benefits of the product or activity are weighed against its dangers."
170. Id. at 6823;
171. see also Hi-Tech Pharms., Inc. v. Crawford, 505 F. Supp. 2d 1341, 1353 (N.D. Ga. 2007) (holding that the proper standard of analysis under Section 342 constitutes the "risk-benefit" balancing test).
172. - 69 Fed. Reg. at 6823.
173. Id. 69 Fed. Reg.
174. See 69 Fed. Reg, at 6788, 6823 (stating that even a significant risk could be "reasonable if the benefits were great enough to outweigh the risks").
175. See Jennifer Akre Hill, Creating Balance: Problems Within DSHEA and Suggestions for Reform, 2 J. FOOD L. & POL' Y 361, 391 (2006) (suggesting that Section 342 divests the FDA of its powers of enforcement).
176. Nutraceutical Corp. v. Crawford (Nutraceutical 7), 364 F. Supp. 2d 1310, 1313 (D. Utah 2005).
177. Id. 364 F. Supp. 2d 1310, (2005)
178. see also Cohen, supra note 11, at 190 (stating that the FDA had been investigating the effects of supplements containing ephedrine alkaloids for nearly seven years, and that the FDA's ban against ephedra marked the first time U.S. officials had blocked the sale of an over- the-counter nutritional supplement on the grounds that it posed a significant and unreasonable risk of barm).
179. Nutraceutical 1, 364 F. Supp. 2d at 1311-14.
180. Id. at 1314.
181. Id. at 1319.
182. Id. at 1319-21.
183. Id. at 1320.
184. Id.
185. Id.
186. Id. at 1320-21.
187. Id. at 1321.
188. Id.
189. Id.
190. Id.
191. Nutraceutical Corp. v. Von Eschenbach {Nutraceutical II), 459 F.3d 1033, 1044 (10th Cir. 2006).
192. Id. at 1041-43.
193. Id. at 1042-43.
194. Id. at 1043-44.
195. See id. at 1042-44 (suggesting that ephedrine alkaloids at any dosage are unsafe and pose a risk of death).
196. See Jennifer Akre Hill, Creating Balance: Problems Within DSHEA and Suggestions for Reform, 2 J. FOOD L. & POL'Y 361, 384 (2006) (stating that under the DSHEA's balancing test, the agency risks losing the benefit of deference in court).
197. The risks associated with ephedrine alkaloids include heart attack, stroke, seizures, and death. Nutraceutical II, 459 F.3d at 1043.
198. - 21 U.S.C. § 342(f)(1)(D) (2006).
199. Id. 21 U.S.C. (2006)
200. See Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 866 (1984) (holding that absent congressional intent, an administrative agency's interpretation of a statute is entitled to judicial deference).
201. See Nutraceutical II, 459 F.3d at 1043 (holding that the "review of scientific literature is properly in the province of the FDA");
202. Weinberger v. Bentex Pharms, Inc., 412 U.S. 645, 653- 54 (1973) (stating that the FDA is "peculiarly suited" to assess conflicting scientific reports, a task "not well left to a court without chemical or medical background, " as it "necessarily implicates complex chemical and pharmacological considerations").
203. Hi-Tech Pharms., Inc. v. Crawford, 505 F. Supp. 2d 1341, 1354 (N.D. Ga. 2007).
204. Nutraceutical Corp. v. Crawford {Nutraceutical I), 364 F. Supp. 2d 1310, 1320-21 (D. Utah 2005).
205. NVE, Inc. v. Dep't of Health & Human Servs. (NVE I), No. 04-cv-999 (JAP), 2004 WL 5561798, at z.ast;2 (D.N.J. Aug. 4, 2004).
206. Id. at z.ast;6 (emphasis added).
207. Id. at z.ast;4.
208. Id. atz.ast;6.
209. NVE, Inc. v. Dep't of Health & Human Servs. (NVE II), 436 F.3d 182, 196-97 (3d Cir. 2006).
210. Id. at 194-95.
211. Id. at 191.
212. Nutraceutical II, 459 F.3d at 1043.
213. Id. at 1037-38.
214. Id. at 1037.
215. The APA vests federal agencies with informal rulemaking authority to implement legislation. Administrative Procedure Act, Pub. L. No. 79-404, 60 Stat. 238 (1946) (codified as amended in scattered sections of 5 U.S.C. (2006);
216. see also William F. Pedersen, Jr., Formal Records and Informal Rulemaking, 85 YALE L.J. 38 (1975) (providing a comprehensive overview of the APA). Under 5 U.S.C. § 706, federal courts can review the propriety of agency rules or actions. Specifically, under 5 U.S.C. § 706(2)(A), private parties can challenge an agency rule or action for being "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law."
217. The FDA can bring enforcement actions against manufacturers under 21 U.S.C. § 332 (2006).
218. NVE, Inc. v. Dep't of Health & Human Servs. (NVEII), 436 F.3d 182, 192 (3d Or. 2006);
219. Nutraceutical II, 459 F.3d at 1037-38.
220. - 21 U.S.C. § 342(0(1) (2000 & Supp. IV 2005).
221. - 21 U.S.C. § 342 (f)(1)(A) (1994).
222. One district court decision supports this interpretation and its application to actions where the government files a complaint for forfeiture of dietary supplements. Hi-Tech Pharms., Inc. v. Crawford, 505 F. Supp. 2d 1341, 1345-46 (N.D. Ga. 2007). Hi-Tech held that where the FDA brings a forfeiture action and lacks the benefit of a regulation to support its contention that a dietary supplement at issue is adulterated, under the DSHEA's "de novo" language, it bears the burden of proof at trial in proving adulteration.
223. Id. at 1By contrast, where the agency has the support of a valid regulation declaring the supplement in question adulterated, then "the court must defer to the agency's regulation and should not review anew the question of adulteration."
224. Id.
225. NVE II, 436 F.3d at 191-92.
226. Id. 436 F.3d.
227. Id. at 192.
228. Id.
229. The Third Circuit inverted this interpretation by stating that Congress did not express "any intention that rulemaking was to be reviewed on a de novo basis, " as there is "no mention in DSHEA of 'review' of agency action." See id. at 191.
230. See Gilhooley, supra note 9, at 702 (taking issue with the DSHEA's passive approach to enforcement and regulation, comparing it to "that used at the beginning of the century").
231. Nutraceutical Corp. v. Von Eschenbach (Nutraceutical II), 459 F.3d 1033, 1039 (10th Or. 2006).
232. By the time the FDA had actually instituted its prohibition against ephedrine alkaloids, the agency had received over 17, 000 adverse event reports stemming from use of supplements containing ephedrine alkaloids. Dietary Supplement Containing Ephedrine Alkaloids, 68 Fed. Reg. 10417, 10418 (Mar. 5, 2003).
233. Fiona LeCong, Food Supplements Directive; An Attempt to Restore the Public Confidence in Food Law, 29 LOY. L.A. INT'L & COMP. L. REV. 105, 106 (2007).
234. Council Directive 2002/46 on the Approximation of the Laws of the Member States Relating to Food Supplements, 2002 O.J. (L 183) 51 (EC) [hereinafter Food Supplements Directive].
235. LeCong, supra note 192, at 109;
236. see also Food Supplements Directive, supra note 193.
237. LeCong, supra note 192, at 109;
238. see also Food Supplements Directive, supra note 193 (providing that "generally acceptable scientific data" should govern the sale and labeling of dietary supplements, and that food supplements should be monitored to ensure safety).
239. LeCong, supra note 192, at 108.
240. McCann, supra note 38, at 254-55;
241. see also George E.C. York, Global Foods, Local Tastes & Biotechnology: The New Legal Architecture of International Agriculture Trade, 7 COLUM. J. EUR. L. 423, 443-46 (2001) (explaining Europe's adherence to the precautionary principle).
242. McCann, supra note 38, at 254-55.
243. See York, supra note 197, at 444-45.
244. LeCong, supra note 192, at 111.
245. Id.
246. See Bruce H. Schindler, Where There's Smoke There's Fire: The Dangers of the Dietary Supplement Industry, 42 N.Y.L. SCH. L. REV. 261, 265-67 (1998) (describing the drug approval process).
247. See generally FDA, Understanding Clinical Trials, http://clinicaltrials. gov/ct2/ info/understand#Q01 (last visited Mar. 19, 2010) [hereinafter FDA, Understanding Clinical Trials].
248. FDA, Understanding Clinical Trials, supra note 202.
249. Id.
250. Id.
251. Id.
252. Id.
253. Id.
254. See Michael Sachs, Ephedra and the Failure of Dietary Supplement Regulation, 54 CATH. U. L. REV. 661, 696 (2005) (arguing that premarket approval for all dietary supplements would "effectively grind the dietary supplement industry to a halt because all dietary supplements would have to apply for premarket certification and an overwhelmed FDA would be unable to act quickly").
255. But see McCann, supra note 38, at 265 (stating that while past studies have demonstrated that vitamin C is safe, recent studies suggest that certain levels of vitamin C consumption might prove harmful).
256. See McCann, supra note 3 8, at 221-22.
257. Id.
258. Id.
259. Id. at 226 (describing the tendency of consumers to equate the word "natural" with "harmless").
260. Or at least Congress concluded so. See 21 U.S.C. § 321(d)(14) (2006) (stating that "dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare"). It may prove difficult to divest Congress of this view, so a testing regime that is just as strict as that employed for drugs probably will not secure wide support.
261. Morgan J. Wais, Stomaching the Burden of Dietary Supplement Safety: The Need to Shift the Burden of Proof Under the Dietary Supplement Health and Education Act of 1994, 28 SEATTLE U. L. REV. 849, 851 (2005).
262. Kaiser, supra note 129, at 1274 (advocating a new regulatory model whereby the FDA must approve all nutraceutical labeling statements).
263. See generally Kathleen M. Boozang, The Therapeutic Placebo: The Case for Patient Deception, 54 FLA. L. REV. 687, 690-91 (2002) (describing the therapeutic potential of placebos in great detail, and suggesting that many of the beneficial effects associated with alternative medicine are based on the "placebo response").
264. See Glen Bradford & Charles C. Elben, The Drug Package Insert and the PDR as Establishing the Standard of Care in Prescription Drug Liability Cases, 57 J. Mo. B. 233, 234 (2001) (describing the role of the prescription drug "insert" contained within the product's package, which is to outline the drug's approved uses, its recommended dosing and duration of use, and its possible beneficial and harmful effects);
265. see also Prescription Drug Insert Information Made Clearer, CNN, Jan. 20, 2006, http://ww.cnn.com/HEALTH/library/DI/00053.html (describing the FDA's efforts to make printed information included with prescription drugs easier for doctors and consumers to understand). The drug insert usually includes possible side effects of the drug and contraindications (conditions that preclude the patient from taking the drug, like an underlying heart problem).
266. McCann, supra note 3 8, at 217.
267. Deborah R. Hensler, The New Social Policy Torts: Litigation as a Legislative Strategy Some Preliminary Thoughts on a New Research Project, 51 DEPAUL L. REV. 493, 497-99 (2001) (discussing, more generally, the role of litigation in encouraging social reform, and more specifically, the positive impact of mass tort litigation on the practices of tobacco companies).
268. Id. at 494.
269. Id.
270. Id. at 506;
271. Ridgeway v. Flagstar Corp., Nos. C 93-20202 JW, C 93-20208 JW (N.D. Cal. 1994).
272. Hensler, supra note 221, at 506.
273. Id. at 507.
274. Id.
275. See Peter D. Jacobson & Shannon Brownlee, The Mass Media's Influence on Health Law and Policy Symposium, 5 Hous. J. HEALTH L. & POL'Y 235, 240-41 (2005) (describing the ways in which criminal trials, like the O.J. Simpson trial, can "create a groundswell of interest" concerning particular issues, and how the media can also change public opinion on managed health care).
276. McCann, supra note 38, at 217.
277. Id.
278. See Eugene S. Suh, Stealing from the Poor to Give to the Rich? California Competition Law Requires Further Reform to Properly Restore Business Stability, 35 Sw. U. L. REV. 229, 239 (2006) (characterizing California's Unfair Competition Law (UCL) prior to the enactment of Proposition 64 as the "most liberal approach to unfair competition law when compared to states with similar provisions"). Proposition 64 imposed new standing requirements on private plaintiffs bringing lawsuits against companies under the UCL. The following Section will discuss the provisions of the UCL and its standing requirements.
279. See Grove Fresh Distribs., Inc. v. Flavor Fresh Foods, 720 F. Supp. 714, 715 (N.D. 1989) (stating that "courts have held that there is no private cause of action under the FDCA");
280. see also NVE, Inc. v. Dep't of Health & Human Servs. {NVEII), 436 F.3d 182, 189 (3d Cir. 2006) (holding that the DSHEA "does not provide a private cause of action");
281. Consumer Justice Ctr. v. Olympian Labs, Inc., 99 Cal. App. 4th 1056, 1063 (Ct. App. 2002) (holding that there is no private cause of action under the FDCA).
282. Consumer Justice Ctr., 99 Cal. App. 4th at 1063 (holding that there is no private cause of action under the FDCA).
283. Cal. Bus. & Prof. Code § 17200 (West 2008).
284. See generally Cel-Tech Commc'ns, Inc. v. L.A. Cellular Tel. Co., 20 Cal. 4th 163, 191-95 (1999).
285. Cal. Bus. & Prof. Code § 17200.
286. Cel-Tech Commc'ns, 20 Cal. 4th at 191-95.
287. Id.
288. Corbett v. Superior Court, 101 Cal. App. 4th 649, 655 (Ct. App. 2002).
289. Cal. Bus. & Prof. Code § 17200.
290. Cel-Tech Commc'ns, 20 Cal. 4th at 191-95.
291. See People v. Regan, 95 Cal. App. 3d Supp. 1, 5-6 (Ct. App. 1979) (holding that where "qualifying words such as knowingly, intentionally, or fraudulently are omitted from provisions creating the offense it is held that guilty knowledge and intent are not elements of the offense");
292. see also Seong Hwan Kim, California's Unfair Competition Act: Will It Give Rise to Another 'Wave' in Smoking and Health Litigation?, 35 SANTA CLARA L. REV. 193, 212 n.97 (1994) (stating that "scienter is not a requisite element of an unfair competition claim").
293. Cmty. Assisting Recovery, Inc. v. Aegis Sec., 92 Cal. App. 4th 886, 892 (Ct. App. 2001).
294. See Kim, supra note 242, at 193, n.97 (1994) (characterizing the UCL as a strict liability law).
295. Id.
296. Nagel v. Twin Labs., Inc., 109 Cal. App. 4th 39, 43 (Dist. Ct. App. 2003).
297. Id. at 52.
298. Id.
299. Id.
300. Id. at 53;
301. - 21 C.F.R. § 101.9(g)(4) (2002).
302. Nagel, 109 Cal. App. 4th at 53.
303. Id. at 55.
304. Pastoria v. Nationwide, 112 Cal. App. 4th 1490, 1498-99 (Ct. App. 2003).
305. People v. McKale, 25 Cal. 3d 626, 632-33 (1979).
306. Id. at 637.
307. Id.
308. Nagel, 109 Cal. App. 4th at 53.
309. The Status of Dietary Supplements in the U.S.: Hearing Before the Subcomm. on Human Rights and Wellness of the H. Comm. on Government Reform, 108th Cong. (2004) (statement of Robert Bracket, Director, FDA, Ctr. for Food Safety and Nutrition), available at http://www.fda.gov/NewsEvents/Testimony/ucml 14758.htm (last visited Mar. 19, 2010).
310. Id.
311. See Suh, supra note 231;
312. see also Cel-Tech Commc'ns, Inc. v. L.A. Cellular Tel. Co., 20 Cal. 4th 163, 183-84 (1999) (illustrating inconsistent case law regarding the types of business practices that qualify as "unfair").
313. See People v. Casa Blanca Convalescent Homes, Inc., 159 Cal. App. 3d 509, 530 (Ct. App. 1984).
314. Smith v. State Farm Mut. Auto. Ins. Co., 93 Cal. App. 4th 700, 719 (Ct. App. 2001).
315. Bardin v. Daimlerchrysler Corp., 136 Cal. App. 4th 1255, 1261 (Ct. App. 2006).
316. Smith v. State Farm Mut. Auto. Ins. Co., 93 Cal. App. 4th 700, 704-06 (Ct. App. 2001).
317. Id. at 718-22.
318. State Farm Fire & Cas. Co. v. Superior Court, 45 Cal. App. 4th 1093, 1104 (Ct. App. 1996).
319. FDA, Recall Notice, Event ID 26400 (June 2, 2003).
320. See 21 U.S.C. § 343(s)(2)(A) (2006) (stating that the label of the supplement must properly list the ingredients of the supplement).
321. Bardin v. Daimlerchrysler Corp., 136 Cal. App. 4th 1255, 1265 (Ct. App. 2006).
322. Smith v. State Farm Mut. Auto. Ins. Co., 93 Cal. App. 4th 700, 719 (Ct. App. 2001).
323. See Suh, supra note 231, at 230 (stating that Proposition 64 imposed a more stringent standing requirement for private plaintiffs bringing suit under the UCL).
324. Id. at 233.
325. Cal. Bus. & Prof. Code § 17204 (West 2008).
326. Hall v. Time, Inc., 158 Cal. App. 4th 847, 849 (Ct. App. 2008);
327. Laster v. T-Mobile USA, Inc., 407 F. Supp. 2d 1181, 1194 (S.D. Cal. 2005).
328. Monarch Plumbing Co. v. Ranger Ins. Co., No. Civ. S-06-1357, 2006 U.S. Dist. LEXIS 68850, at *20 (E.D. Cal. Sept. 25, 2006).
329. S. Cal. Hous. Rights Ctr. v. Los Feliz Towers Homeowners Ass'n Bd., 426 F. Supp. 2d 1061, 1069 (CD. Cal. 2005).
330. Cal. Bus. & Prof. Code § 17204.
331. See S. Cal. Hous. Rights Ctr., 426 F. Supp. 2d at 1069 (stating that the loss of financial resources meets the injury requirement under the UCL).
332. Id., 426, F. Supp. 2d
333. Kraus v. Trinity Mgmt. Servs., Inc., 23 Cal. 4th 116, 127 (2000) (holding that disgorgement as a restitutionary remedy in class action suits is available under Section 17200).
334. Cal. Civ. Code § 1750 (West 2009).
335. Cal. Civ. Code § 1770.
336. Cal. Civ. Code § 1770(a)( 1H23).
337. Trenton H. Norris, Consumer Litigation & FDA-Regulated Products: The Unique State of California, 61 Food & Drug L.J. 547, 558 (2006).
338. Kagan v. Gibraltar Sav. & Loan Ass'n, 35 Cal. 3d 582, 593 (1984).
339. Id. at 590.
340. Id.
341. Lazar v. Hertz Corp., 143 Cal. App. 3d 128, 142 (Ct. App. 1983).
342. Cal. Civ. Code § 1770(a)(2) (West 2009).
343. Chamberlan v. Ford Motor Co., 369 F. Supp. 2d 1138, 1144 (N.D. Cal. 2005);
344. see also Consumer Advocates v. EchoStar Satellite Corp., 113 Cal. App. 4th 1351, 1361 (Ct. App. 2003) (holding that statements akin to "mere puffing" do not give rise to liability).
345. See Consumer Advocates, 113 Cal. App. 4th at 1360 (holding that the standard for determining whether a statement by a company is deceptive, for all statutory causes of action, is based on the effect it would have on a reasonable consumer).
346. Delahunt v. Cytodyne Techs, 241 F. Supp. 2d 827, 834-36 (S.D. Ohio 2003).
347. Id.
348. McClain v. Metabolife Int'l, Inc., 193 F. Supp. 2d 1252, 1254-57 (N.D. Ala. 2002).
349. Id. at 1257.
350. For a helpful discussion on preemption, see In re Farm Raised Salmon Cases, 42 Cal. 4th 1077, 1089-98 (2008) (suggesting in dictum that a plaintiff would be barred by the doctrine of preemption from invoking a violation of the FDCA in order to bring a UCL claim against a food manufacturer).
351. See Norris, supra note 284, at 550 (arguing that a court's calculation of the risks posed by a particular drug or food article may conflict with the FDA's calculation of that risk).
352. Consumer Justice Ctr. v. Olympian Labs, Inc., 99 Cal. App. 4th 1056, 1058-66 (Ct. App. 2002).
353. Id. at 1063.
354. Id. at 1063.
355. Id. at 1062.
356. Id. at 1064.
357. Id. atl062n.8.
358. Id. at 1059.
359. Stephanie Kauflin, Dietary Supplements: Is Availability Worth the Risks? Proposed Alternatives to the Present DSHEA Scheme, 33 Seton Hall L. Rev. 411, 432 (2003) (suggesting that because Congress' purpose in passing the DSHEA was to make dietary supplements more accessible to consumers, any state law undermining that purpose triggers the possibility of preemption).
360. Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n, 447 U.S. 557, 563-64 (1980).
361. Id. at 566.
362. Pearson v. Shalala, 164 F.3d 650, 655 (D.C. Cir. 1999).
363. Id. at 658.
364. Id.
365. Id. at 660-61.
366. Id. at 655.
367. Id. at 659-60.
368. Id.
369. Id. at 654.
370. Id. at 659.
371. Id. at 659-60.
372. Id.
373. Id.
374. Id. at 659.
375. See McCann, supra note 38, at 218 (stating that in 2003, the dietary supplement industry recorded $20.1 billion dollars in sales).